Access to the most popular abortion method in the United States plunged into uncertainty Friday after conflicting rulings on the legality of the abortion drug mifepristone that has been widely available for more than 20 years.
For now, the drug approved by the Food and Drug Administration in 2000 remains available at least immediately in the wake of separate rulings handed down a few minutes apart by federal judges in Texas and Washington.
US District Judge Matthew Kaczmarek, a Trump appointee, ordered a suspension of federal approval of mifepristone in a decision that invalidated decades of scientific approval. But this decision was quickly followed by US District Judge Thomas O. Rice, who was appointed by Obama, ordering essentially the opposite and directing US authorities not to make many changes that would restrict access to the property.
The extraordinary timing of the competing orders exposed the significant stakes surrounding the drug a year after the United States Supreme Court overturned Roe v. Wade and reduced access to abortion across the country.
“The FDA has one thing saying you can’t do anything, and another thing saying within seven days I’m going to ask you to revoke approval for mifepristone,” said Glenn Cohen of Harvard Law School.
The immediate impact of Kazmaric’s ruling, which did not take effect immediately, was not clear.
The abortion drug has been widely used in the United States since 2000, and there is no fundamental precedent for a single judge overruling FDA medical decisions. Mifepristone is one of the drugs used in medical abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.
Kacsmaryk, a Trump administration appointee in Amarillo, Texas, signed an injunction directing the Food and Drug Administration to stay approved of mifepristone while a lawsuit challenging the drug’s safety and approval continues. His 67-page order gave the government seven days to appeal.
“Simply put, the FDA has blocked judicial review—until now,” Kaksmarek wrote.
It did not go beyond requiring the plaintiffs to withdraw or suspend approval of the chemical abortion drug and remove it from the list of approved drugs. But he stopped or stopped approving the drug.
Federal attorneys representing the FDA are expected to appeal quickly.
Clinics and doctors prescribing the combination of the two drugs said that if mifepristone is pulled off the market, they will switch to using only the second drug, misoprostol. This single-drug approach has a slightly lower efficacy rate for terminating pregnancy, but is widely used in countries where mifepristone is illegal or unavailable.
Mifepristone is part of a two-drug regimen that has long been the standard for medical abortion in US clinics, and doctors who prescribe the combination say they plan to switch to using only misoprostol. The single-drug approach is less effective in terminating a pregnancy.
The suit was brought by the Freedom Defense Coalition, which was also involved in the Mississippi case that led to Roe v. Wade being thrown out. The crux of the lawsuit is the claim that the FDA’s initial approval of mifepristone was flawed because it did not adequately review the safety risks.
Courts have long turned to the Food and Drug Administration on issues of drug safety and efficacy. But the agency’s authority faces new challenges in the post-Rowe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws that specifically target abortion drugs.
Update, April 7, 2023: This article has been updated with additional information And a new address